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The evaluations were conducted on nine scale-up DOE development batches and eight clinical sub-lots.
The first 29 development batches of DPC 961 involved isolation of the API through crystallization from toluene/heptane, followed by re-crystallization from methanol (MeOH).
The final production sizes of these small lot sizes, denoted by contract manufacturers as research and development batches or Clinical Trial Manufacturing (CTM) batches, are within the range of 10,000 to 50,000 units.
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Thus, the Committee is now discussing ways to confirm consistency of the dissolution behavior within the development batch (i.e., biobatch).
The customization and the automated model hyper-parameter selection provide the tools necessary for automated model development, batch generation of models and the assessment of multiple model hypothesis.
The first three Sea Harriers were a development batch and were used for clearance trials.
Under the "development batch" procedure pioneered by the Americans (and also used by English Electric for the Lightning), there would instead be a development batch of nine airframes, to be built using production jigs.
Despite the increasing costs (which were inevitable, given the low original estimates), the first two of the development batch aircraft were completed.
The maiden flight of the second development batch aircraft, XR220, was due on the day of the announcement, but following an accident in conveying the airframe to Boscombe Down, coupled with the announcement of the project cancellation, it never happened.
(A) Exposed films were first put into a rack for development in batch.
Inherent process and measurement uncertainty has posed a challenging issue on soft sensor development of batch bioprocesses.
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CEO of Professional Science Editing for Scientists @ prosciediting.com